Results 91 to 100 of about 26,646 (226)

Advancing Pharmacoequity in Low‐ and Middle‐Income Countries via Model Informed Drug Development

Clinical and Translational Science, Volume 19, Issue 5, May 2026.
ABSTRACT Across low‐ and middle‐income countries (LMICs) inequities in access to safe, effective medicines persist due to limited regulatory capacity, inadequate financing, and insufficient local data. Regulatory authorities are engaging with model‐informed drug development (MIDD), but uneven technical readiness and resource gaps limit uptake ...
Henry Enzama, Francis Williams Ojara, Ian S. Haworth, Sandra Cvijic, Catriona Waitt, Thaddeus H. Grasela   +5 more
wiley   +1 more source

Formulation and Stability Study of Eslicarbazepine Acetate Oral Suspensions for Extemporaneous Compounding [PDF]

, 2018
Eslicarbazepine acetate is an anticonvulsant drug with a recent U.S. Food and Drug Administration approval for expanded use in children and adolescents. Currently, eslicarbazepine acetate is only available in the U.S. as 200-mg to 800-mg strength tablets
Dave, Vivek S, Mar, Mazin Z., Perri, Jonathan R., Zhao, Fang   +3 more
core   +1 more source

A single-dose, randomized, open-label, four-period, crossover equivalence trial comparing the clinical similarity of the proposed biosimilar rupatadine fumarate to reference Wystamm® in healthy Chinese subjects

Frontiers in Pharmacology
PurposeThe aim of this study was to evaluate the bioequivalence of two formulations of rupatadine (10-mg tablets) under fasting and fed conditions in healthy Chinese subjects.MethodsA total of 72 subjects were randomly assigned to the fasting cohort (n =
Sisi Lin, Yutao Lou, Rui Hao, Yiming Shao, Jin Yu, Lu Fang, Meihua Bao, Wu Yi, Yiwen Zhang, Yiwen Zhang, Yiwen Zhang   +10 more
doaj   +1 more source

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

Clinical and Translational Science, 2019
In this paper, a special case for bioequivalence evaluation of oral formulations is discussed. Drug formulations with different forms of active moieties (e.g., free base and salt) may yield different dissolution characteristics and, thus, differ in ...
Hao Zhu, Xiaomei Chen, Mariam Ahmed, Yaning Wang, Qi Liu, Ramana S. Uppoor, Colleen Kuemmel, Mehul Mehta   +7 more
doaj   +1 more source

From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus^®-Driven Framework for Generic Candesartan Cilexetil Tablets

Pharmaceuticals
Background: Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first ...
Hao Ruan, Xiaoting Geng, Zijing Situ, Qian Shen, Tianjian Ye, Xin Chen, Weike Su   +6 more
doaj   +1 more source

SIMULATION OF BIOEQUIVALENCE STUDY ON THE BASE OF DISSOLUTION CURVES [PDF]

, 2018
A computer method and software based on the in vitro dissolution ofdrug preparations has been elaborated for the estimation of bioequivalenceusing Microsoft Excel 2007, Visual Basic programming language.
Dinya, Elek, Grézal Gyula, Grézal Gábor, Tóth, Tamás   +3 more
core  

Update on the advances and challenges in bioequivalence testing methods for complex topical generic products

Frontiers in Pharmacology
Most of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence.
Nedaa Alomari, Waleed Alhussaini
doaj   +1 more source

Comparison of tape stripping with the human skin blanching assay for the bioequivalence assessment of topical clobetasol propionate formulations.

Journal of Pharmacy & Pharmaceutical Sciences, 2010
Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn.
Wai Ling Au, Michael F Skinner, Isadore Kanfer   +2 more
doaj   +1 more source

The impact of the reference price system on the pharmaceutical market: A theoretical approach [PDF]

This article analyses the impact of the reference price system on the price-setting strategies of the pharmaceutical firms and on the level of generic usage.
Anna Merino
core